Why it was recalled
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Product description
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60
Lot numbers, UPCs & expiration codes
Lot #, DI2303B, Exp 12/31/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0599-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 24, 2024
- FDA report date
- Jul 17, 2024
- Quantity
- 868 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rising Pharma Holding, Inc.
Original FDA data
Every field from FDA enforcement report D-0599-2024, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94854
- Address
- 2 Tower Center Blvd Ste 1401
- Code information
- Lot #, DI2303B, Exp 12/31/2024
- Postal code
- 08816-1149
- Report date
- Jul 17, 2024
- Product type
- Drugs
- Recall number
- D-0599-2024
- Classification
- Class III
- Recalling firm
- Rising Pharma Holding, Inc.
- Product quantity
- 868 tubes
- Reason for recall
- Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 24, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 16, 2024